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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antinuclear antibody (enzyme-labeled), antigen, controls
510(k) Number K833148
Device Name ENZYME ANA TEST SYSTEM
Applicant
IMMUNO CONCEPTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
IMMUNO CONCEPTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.5100
Classification Product Code
LJM  
Date Received09/15/1983
Decision Date 11/21/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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